Performance of free beta-human chorionic gonadotrophin (free beta-hCG) and pregnancy associated plasma protein-A (PAPP-A) analysis between Delfia Xpress and AutoDelfia systems in The Netherlands

Clin Chem Lab Med. 2009;47(2):222-6. doi: 10.1515/CCLM.2009.042.

Abstract

Background: The VU University Medical Center (VUmc) was the first hospital in the Netherlands to introduce the Delfia Xpress for the analysis of free beta-human chorionic gonadotrophin (beta-hCG) and pregnancy associated plasma protein-A (PAPP-A) in the first trimester screening program for Down syndrome. Since then, others have implemented this system. In this study, we tested the equality of measurements for free beta-hCG and PAPP-A between Delfia Xpress systems and one AutoDelfia system.

Methods: A total of 40 serum samples were aliquoted and stored at -20 degrees C. Samples were analyzed by six Delfia Xpress systems and one AutoDelfia system over a time period of 2 years.

Results: The relationships between free beta-hCG and PAPP-A were excellent for the different Delfia Xpress systems (r>0.99, p<0.0001). For PAPP-A, the agreement between the main system at VUmc and five other systems was linear with slopes between 0.99 and 1.06. Similarly, agreement for free beta-hCG was linear with slopes between 0.99 and 1.09. Likewise, agreement for PAPP-A and free beta-hCG was excellent for the AutoDelfia vs. the main Delfia Xpress at the VUmc (r>0.99, p<0.0001). For both PAPP-A and free beta-hCG, the relationships were linear with slopes of 1.08 and 1.07.

Conclusions: We demonstrate an excellent agreement for the analysis of PAPP-A and free beta-hCG between Delfia Xpress systems and one AutoDelfia system.

Publication types

  • Comparative Study

MeSH terms

  • Chorionic Gonadotropin, beta Subunit, Human / blood*
  • Down Syndrome / blood
  • Down Syndrome / diagnosis
  • Humans
  • Immunoassay / instrumentation
  • Immunoassay / methods*
  • Netherlands
  • Predictive Value of Tests
  • Pregnancy-Associated Plasma Protein-A / analysis*
  • Reagent Kits, Diagnostic
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Chorionic Gonadotropin, beta Subunit, Human
  • Reagent Kits, Diagnostic
  • Pregnancy-Associated Plasma Protein-A